Trial Outcomes & Findings for A Comparison of AIR OPTIX® COLORS Versus FRESHLOOK® COLORBLENDS (NCT NCT01635933)
NCT ID: NCT01635933
Last Updated: 2014-05-09
Results Overview
Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.
COMPLETED
NA
370 participants
Up to Day 28
2014-05-09
Participant Flow
Participants were recruited from 24 study centers located in the United States.
Of the 370 participants enrolled and randomized, 4 did not meet inclusion/exclusion criteria, 2 were lost to follow-up, and 1 declined participation. This reporting group includes all participants exposed to the study product (363).
Participant milestones
| Measure |
AIR OPTIX® COLORS
Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
|
FRESHLOOK® COLORBLENDS
Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
|
|---|---|---|
|
Overall Study
STARTED
|
178
|
185
|
|
Overall Study
COMPLETED
|
176
|
177
|
|
Overall Study
NOT COMPLETED
|
2
|
8
|
Reasons for withdrawal
| Measure |
AIR OPTIX® COLORS
Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
|
FRESHLOOK® COLORBLENDS
Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
5
|
|
Overall Study
Subject decision
|
1
|
1
|
|
Overall Study
Noncompliance
|
0
|
1
|
|
Overall Study
No longer had transportation
|
0
|
1
|
Baseline Characteristics
A Comparison of AIR OPTIX® COLORS Versus FRESHLOOK® COLORBLENDS
Baseline characteristics by cohort
| Measure |
AIR OPTIX® COLORS
n=178 Participants
Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
|
FRESHLOOK® COLORBLENDS
n=185 Participants
Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
|
Total
n=363 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
16-17 years
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Age, Customized
18-64 years
|
167 participants
n=5 Participants
|
174 participants
n=7 Participants
|
341 participants
n=5 Participants
|
|
Age, Customized
≥65 years
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
164 Participants
n=5 Participants
|
166 Participants
n=7 Participants
|
330 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 28Population: The analysis population includes all enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=178,185). No imputation was used for the missing values. Here, "n" is the number of participants with non-missing values at the specific time point for each arm group.
Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.
Outcome measures
| Measure |
AIR OPTIX® COLORS
n=178 Participants
Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
|
FRESHLOOK® COLORBLENDS
n=185 Participants
Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
|
|---|---|---|
|
Subjective Rating of Overall Comfort
Day 14 (n=175,181)
|
8.7 Units on a scale
Standard Deviation 1.7
|
8.6 Units on a scale
Standard Deviation 1.8
|
|
Subjective Rating of Overall Comfort
Day 28 (n=176,176)
|
8.7 Units on a scale
Standard Deviation 1.7
|
8.5 Units on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Up to Day 28Population: The analysis population includes all enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=178,185). No imputation was used for the missing values. Here, "n" is the number of participants with non-missing values at the specific time point for each arm group.
Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.
Outcome measures
| Measure |
AIR OPTIX® COLORS
n=178 Participants
Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
|
FRESHLOOK® COLORBLENDS
n=185 Participants
Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
|
|---|---|---|
|
Subjective Rating of Overall Vision
Day 14 (n=175,181)
|
8.8 Units on a scale
Standard Deviation 1.6
|
8.7 Units on a scale
Standard Deviation 1.5
|
|
Subjective Rating of Overall Vision
Day 28 (n=176,177)
|
8.9 Units on a scale
Standard Deviation 1.5
|
8.7 Units on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Day 28Population: The analysis population includes all enrolled and dispensed participants who had at least 1 study visit after being dispensed the study lenses. No imputation was used for missing values.
Participants were asked to compare the study lenses to their habitual lenses using a 5-point scale: strongly prefer study lenses, somewhat prefer study lenses, no preference, somewhat prefer habitual lenses, and strongly prefer habitual lenses, where 'study lenses' refer to either test or control depending on the treatment group. Proportion of subjects preferring study lens is reported as the percentage of participants who strongly or somewhat preferred the study lens.
Outcome measures
| Measure |
AIR OPTIX® COLORS
n=175 Participants
Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
|
FRESHLOOK® COLORBLENDS
n=177 Participants
Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
|
|---|---|---|
|
Proportion of Subjects Preferring Study Lens (Strongly or Somewhat)
|
54.3 Percentage of participants
|
45.2 Percentage of participants
|
Adverse Events
AIR OPTIX® COLORS
FRESHLOOK® COLORBLENDS
Serious adverse events
| Measure |
AIR OPTIX® COLORS
n=178 participants at risk
Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
|
FRESHLOOK® COLORBLENDS
n=185 participants at risk
Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/178 • Adverse Events (AE) were collected for the duration of the study (3 months). AEs were obtained as solicited comments from subjects and as observations by the study Investigator as outlined in the study protocol.
The analysis population includes all participants exposed to the study product. An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings), whether or not related to the investigational medical device.
|
0.54%
1/185 • Adverse Events (AE) were collected for the duration of the study (3 months). AEs were obtained as solicited comments from subjects and as observations by the study Investigator as outlined in the study protocol.
The analysis population includes all participants exposed to the study product. An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings), whether or not related to the investigational medical device.
|
|
Injury, poisoning and procedural complications
Injury
|
0.56%
1/178 • Adverse Events (AE) were collected for the duration of the study (3 months). AEs were obtained as solicited comments from subjects and as observations by the study Investigator as outlined in the study protocol.
The analysis population includes all participants exposed to the study product. An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings), whether or not related to the investigational medical device.
|
0.00%
0/185 • Adverse Events (AE) were collected for the duration of the study (3 months). AEs were obtained as solicited comments from subjects and as observations by the study Investigator as outlined in the study protocol.
The analysis population includes all participants exposed to the study product. An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings), whether or not related to the investigational medical device.
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/178 • Adverse Events (AE) were collected for the duration of the study (3 months). AEs were obtained as solicited comments from subjects and as observations by the study Investigator as outlined in the study protocol.
The analysis population includes all participants exposed to the study product. An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings), whether or not related to the investigational medical device.
|
0.54%
1/185 • Adverse Events (AE) were collected for the duration of the study (3 months). AEs were obtained as solicited comments from subjects and as observations by the study Investigator as outlined in the study protocol.
The analysis population includes all participants exposed to the study product. An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings), whether or not related to the investigational medical device.
|
Other adverse events
Adverse event data not reported
Additional Information
Sharon Holden Thomas, O.D., Sr. Principal Clinical Scientist
Alcon Research, Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER